Systems and methods to provide communication, positioning and monitoring of user status

ABSTRACT

A communication apparatus includes a bone conduction communication apparatus with a housing having a shape which is conformable to at least a portion of at least one tooth of a user; a transceiver mounted in the housing; and a transducer disposed within or upon the housing and in vibratory communication with a surface of the at least one tooth to transmit sound through the at least one tooth. A positioning system is provided to transmit positional information to the transceiver to be delivered to the transducer: and a communication device links the transceiver with a second person. The electronic and transducer assembly may receive incoming sounds either directly or through a receiver to process and amplify the signals and transmit the processed sounds via a vibrating transducer element coupled to a tooth or other bone structure, such as the maxillary, mandibular, or palatine bone structure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/580,142 filed Oct. 15, 2009, which is a continuation-in-part of U.S.patent application Ser. No. 12/252,613 filed Oct. 16, 2008 and acontinuation-in-pan of U.S. patent application Ser. No. 11/754,823 filedMay 29, 2007, now U.S. Pat. No, 7,844,064 issued Nov. 30, 2010, thecontents of which are incorporated herein by reference in theirentirety.

BACKGROUND

In most countries special forces (SF) is a generic term forhighly-trained military teams/units that conduct specialized operationssuch as reconnaissance, unconventional warfare, and counter-terrorismactions. (In the United States, the term Special Operations Forces (SOF)is used instead of special forces to refer to the aforementioned unitsbecause Special Forces refers to a specific unit, the United States ArmySpecial Forces aka “Green Berets”.)

Special operations forces conduct worldwide special operations in peaceand war in support of regional combatant commanders, ambassadors, andthe National Command Authorities. Special operations forces serve threestrategic purposes that are increasingly important in the current andfuture international environment. First, they offer a range of optionsto decision makers confronting crises and conflicts below the thresholdof war, such as terrorism, insurgency, and sabotage. Second, they areforce multipliers for major conflicts, increasing the effectiveness andefficiency of the military effort. They are also the forces of choice insituations requiring regional orientation and cultural and politicalsensitivity, including military-to-military contacts and noncombatantmissions like humanitarian assistance, security assistance, andpeacekeeping operations.

These forces engage in high risk jobs and have special needs fornavigating in unfamiliar terrain, for communicating and coordinatingwith team members, and protection from gunshots and explosions.Conventional approaches include bullet-proof glass, concrete and steelbuilding structures, armored cars, bullet-proof jackets, and others. Theparticular avenue taken depends on whether the person is stationary,located in a vehicle, located within a building, or is required tomaintain mobility outside the confines of any specific stationarystructure,

SUMMARY

In one aspect, a communication apparatus includes a bone conductioncommunication apparatus with a housing having a shape which isconformable to at least a portion of at least one tooth of a user; atransceiver mounted in the housing; and a transducer disposed within orupon the housing and in vibratory communication with a surface of the atleast one tooth to transmit sound through the at least one tooth. Apositioning system is provided to transmit navigational instructions tothe transceiver to be delivered to the transducer; and a long rangesecure communication radio links the transceiver with a remote person.

Implementations of the above aspect may include one or more of thefollowing. A hearing protection unit can be inserted or positionedwithin or in proximity to the user's ear. The protection unit can be anoise cancellation device or can be a simple plug to block Out sound andto focus hearing on bone-conducted sound rather than sound comingthrough the ear canal. The positioning system and the transducer provideturn by turn audio navigation instructions to the user. The long rangesecure communication radio transmits the user's position to a remotemonitoring center. The long range secure communication radio isinteroperable with a plurality of tactical radios and intercom system.The long range secure communication radio can be a plurality of tacticalradios and an intercom system. A user interface allows the user tochange radio channel and radio volume. The user interface can be mountedon a weapon rail to enable the user to control the channel and volumewithout removing the user's hand. The user interface can be voiceactivated to enable hands-free operation. A motion sensor to detect aforce imposed on the user may be included as part of the presentinvention. A protective vest can he worn by the user and actuated by themotion sensor. The protective vest can inflate when the motion sensordetects an incoming force. For example, the protective vest is actuatedby a blast. A helmet can be worn, and a linkage can be used with thevest and a helmet, the linkage being hardened when the blast is detectedto protect the user's neck. A controller can be used with thetransceiver to disable the communication apparatus when worn by anunauthorized user. The motion sensor captures a blast vector comprisingdirection and magnitude of a blast.

In another aspect, a bone conduction communication apparatus includes ahousing having a shape which is conformable to at least a portion of atleast one tooth of a user; a motion sensor to detect a force imposed onthe user; an actuatable transducer disposed within or upon the housingand in vibratory communication with a surface of the at least one tooth;and a wireless satellite transceiver coupled to the motion sensor tocommunicate the force and coupled to the transducer to provide receivedsound to the user and to support global communication for the user.

In yet another aspect, an electronic and transducer device can beattached, adhered, or otherwise embedded into or upon a removable oralappliance or other oral device to form a two-way communication assembly.The device contains a motion sensor to detect external forces imposed onthe user such as an explosion, for example. The information is storedfor medical treatment, among others. In another embodiment, the deviceprovides an electronic and transducer device that can be attached,adhered, or otherwise embedded into or upon a removable oral applianceor other oral device to form a medical tag containing patientidentifiable information. Such an oral appliance may be a custom-madedevice fabricated from a thermal forming process utilizing a replicatemodel of a dental structure obtained by conventional dental impressionmethods. The electronic and transducer assembly may receive incomingsounds either directly or through a receiver to process and amplify thesignals and transmit the processed sounds via a vibrating transducerelement coupled to a tooth or other bone structure, such as themaxillary, mandibular, or palatine bone structure.

The system reduces paperwork, allows for the collection of more completepatient information, eliminates redundant data entry, increasesresponsiveness to medical situations and enables healthcare providers tomake certain all patient episodes are captured and recorded no matterthe environment. The system provides a standard of care to soldiers (asused herein, soldiers also include SOF) by providing access topreviously unavailable information. The system is a multi-purposemedical platform that is rugged, wireless and secure. The systemprovides commanders with real time visibility of their readiness statusand provides support for medical command and control, telemedicine andmedical informatics applications across the continuum of the entirespectrum of military medical operations but especially for the firstresponder and far forward medical facilities. With soldiers deployed inmany different parts of the world, the system allows medicalprofessionals to capture patient episodes anywhere, anytime, and ensurecomplete patient information is recorded and transferred to thesoldier's medical record at home.

Certain embodiments of the system automatically inflates Kevlar coatedjackets and helmets to protect the user from the forces of blasts orexplosions. These embodiments receive the output of the motion sensorsand detect the presence of blasts/explosions and cause the vests/helmetsto become hardened to protect the wearer from the blasts/explosions. Thesystem can provide an automated introduction of a protective, inflatableshield between the concussive force of a bomb blast or the impact energyof a projectile, and the body of the person at which it is directed.

The system is uniquely tailored to the individual and can containtamper-proof electronics that disable the system if the system isremoved from the authorized user and tampered with in order to be usedby an unauthorized user. In this manner, the system is highly secured.Due to the security, the system can provide a dental identificationmeans which is retained on the individual and thus is less subject todestruction, loss, forgetfulness, or any of the numerous other problems.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a first embodiment of an exemplary communication deviceand/or medical monitoring device.

FIG. 1B shows a second embodiment of an exemplary communication deviceand/or medical monitoring device.

FIG. 1C shows a third embodiment of an exemplary communication deviceand/or medical monitoring device.

FIG. 1D illustrates the dentition of a patient's teeth and one variationof a two-way communication device which is removably placed upon oragainst the patient's tooth or teeth as a removable oral appliance.

FIG. 2A illustrates a perspective view of the lower teeth showing oneexemplary location for placement of the removable oral appliance two-waycommunication device.

FIG. 2B illustrates another variation of the removable oral appliance inthe form of an appliance which is placed over an entire row of teeth inthe manner of a mouthguard.

FIG. 2C illustrates another variation of the removable oral appliancewhich is supported by an arch.

FIG. 2D illustrates another variation of an oral appliance configured asa mouthguard.

FIG. 3 illustrates a detail perspective view of the oral appliancepositioned upon the patient's teeth utilizable in combination with atransmitting assembly external to the mouth and wearable by the patientin another variation of the device.

FIG. 4 shows an illustrative configuration of the individual componentsin a variation of the oral appliance device having an externaltransmitting assembly with a receiving and transducer assembly withinthe mouth.

FIG. 5 shows an illustrative configuration of another variation of thedevice in which the entire assembly is contained by the oral appliancewithin the user's mouth.

FIG. 6A shows a partial cross-sectional view of an oral appliance placedupon a tooth with an electronics/transducer assembly adhered to thetooth surface via an adhesive.

FIG. 6B shows a partial cross-sectional view of a removable backingadhered onto an adhesive surface.

FIG. 7 shows a partial cross-sectional view of another variation of anoral appliance placed upon a tooth with an electronics/transducerassembly pressed against the tooth surface via an osmotic pouch.

FIG. 8 shows a partial cross-sectional view of another variation of anoral appliance placed upon a tooth with an electronics/transducerassembly pressed against the tooth surface via one or more biasing,elements.

FIG. 9 illustrates another variation of an oral appliance having anelectronics assembly and a transducer assembly separated from oneanother within the electronics and transducer housing of the oralappliance.

FIGS. 10 and 11 illustrate additional variations of oral appliances inwhich the electronics and transducer assembly are maintainable againstthe tooth surface via a ramped surface and a biasing element.

FIG. 12 shows yet another variation of an oral appliance having aninterfacing member positioned between the electronics and/or transducerassembly and the tooth surface.

FIG. 13 shows yet another variation of an oral appliance having anactuatable mechanism for urging the electronics and/or transducerassembly against the tooth surface.

FIG. 14 shows yet another variation of an oral appliance having a cammechanism for urging the electronics and/or transducer assembly againstthe tooth surface.

FIG. 15 shows yet another variation of an oral appliance having aseparate transducer mechanism positionable upon the occlusal surface ofthe tooth for transmitting vibrations.

FIG. 16 illustrates another variation of an oral appliance having amechanism for urging the electronics and/or transducer assembly againstthe tooth surface utilizing a bite actuated mechanism.

FIG. 17 shows yet another variation of an oral appliance having acomposite dental anchor for coupling the transducer to the tooth.

FIGS. 18A and 18B show side and top views, respectively, of an oralappliance variation having one or more transducers which may bepositioned over the occlusal surface of the tooth.

FIGS. 19A and 19B illustrate yet another variation of an oral appliancemade from a shape memory material in its pre-formed relaxedconfiguration and its deformed configuration when placed over or uponthe patient's tooth, respectively, to create an interference fit.

FIG. 20 illustrates yet another variation an oral appliance made from apre-formed material in which the transducer may be positioned betweenthe biased side of the oral appliance and the tooth surface.

FIG. 21 illustrates a variation in which the oral appliance may beomitted and the electronics and/or transducer assembly may be attachedto a composite dental anchor attached directly to the tooth surface.

FIGS. 22A and 22B show partial cross-sectional side and perspectiveviews, respectively, of another variation of an oral appliance assemblyhaving its occlusal surface removed or omitted for patient comfort.

FIGS. 23A and 23B illustrate perspective and side views, respectively,of an oral appliance which may be coupled to a screw or post implanteddirectly into the underlying bone, such as the maxillary or mandibularbone.

FIG. 24 illustrates another variation in which the oral appliance may becoupled to a screw or post implanted directly into the palate of apatient.

FIGS. 25A and 25B illustrate perspective and side views, respectively,of an oral appliance which may have its transducer assembly or acoupling member attached to the gingival surface to conduct vibrationsthrough the gingival tissue and underlying bone.

FIG. 26 illustrates an example of how multiple oral appliance two-waycommunication assemblies or transducers may be placed on multiple teeththroughout the patient's mouth.

FIGS. 27A and 27B illustrate perspective and side views, respectively,of an oral appliance (similar to a variation shown above) which may havea microphone unit positioned adjacent to or upon the gingival surface tophysically separate the microphone from the transducer to attenuate oreliminate feedback.

FIG. 28 illustrates another variation of a removable oral appliancesupported by an arch and having a microphone unit integrated within thearch.

FIG. 29 shows yet another variation illustrating at least one microphoneand optionally additional microphone units positioned around the user'smouth and in wireless communication with the electronics and/ortransducer assembly.

DESCRIPTION

As shown in FIG. 1A, an exemplary two way hands-free communication andposition determination monitoring device is shown. In FIG. 1A, thecommunication and monitoring device includes a bone conductioncommunication apparatus 1 with a housing having a shape which isconformable to at least a portion of at least one tooth of a user. Thebone conduction communication apparatus 1 includes a short-range, lowpower transceiver mounted in the housing; and a transducer disposedwithin or upon the housing and in vibratory communication with a surfaceof the at least one tooth to transmit sound through the at least onetooth. A positioning, system 2 is provided to transmit navigationalinstructions to the transceiver to he delivered to the transducer; and along range secure communication radio 3A links the transceiver with aremote server 5A and/or a remote person for voice communication.

To protect the user from loud noises such as gun noises, a hearingprotection unit can be inserted or positioned within or in proximity tothe user's ear. The protection unit can be a noise cancellation deviceor can be a simple plug to block out sound and to focus hearing onbone-conducted sound rather than sound coming through the ear canal.

During missions, the positioning system 2 sends turn by turn audionavigation instructions to the user through the short-range low powertransceiver. The long range secure communication radio 3A transmits theuser's position to a remote monitoring center that can include people aswell as communication servers. The long range secure communication radio3A is interoperable with a plurality of tactical radios and intercomsystem. The long range secure communication radio 3A can be a pluralityof tactical radios and an intercom system. A user interface allows theuser to change radio channel and radio volume. The user interface can bemounted on a weapon rail to enable the user to control the channel andvolume without removing the user's hand. The user interface can be voiceactivated to enable hands-free operation. A motion sensor to detect aforce imposed on the user may be included as part of the presentinvention. As shown in FIG. 1C, a protective vest can be worn by theuser and actuated by the motion sensor. The protective vest can inflatewhen the motion sensor detects an incoming force. For example, theprotective vest is actuated by a blast. A helmet can be worn, and alinkage can be used with the vest and a helmet, the linkage beinghardened when the blast is detected to protect the user's neck. Acontroller can be used with the transceiver to disable the communicationapparatus when worn by an unauthorized user. The motion sensor capturesa blast vector comprising direction and magnitude of a blast.

In the embodiment of FIG. 1C, the device 1 is mounted in the user'smouth. More details on the intraoral device 1 are discussed below. Thedevice 1 can communicate with the positioning device 2 such as GPS,GLONASS, or Galileo. Additionally, one or more body mounted sensors canbe adjacent the positioning device 2 and they can communicate with otherelectronics through a short range personal area network (PAN). Thedevice 1 can also communicate with an attention device 4 such as aflashing light, among others. In case of an emergency with poorvisibility, the attention device 4 can be activated to identify thewearer so that assistance can be rendered quickly. The device 1, thesensor 2 and attention device 4 communicates with a long rangetransceiver 3A. In the embodiment of FIG. 1A, the system communicatesthrough a remote server 5A over a long range wireless area network suchas WiMAX. In FIG. 1B, a transceiver 3B is a cellular transceiver thatcommunicates with cellular towers 5B, for example.

In one embodiment, the device 1 provides an electronic and transducerdevice that can he attached, adhered, or otherwise embedded into or upona removable oral appliance or other oral device to form a medical tagcontaining patient identifiable information. Such an oral appliance maybe a custom-made device fabricated from a thermal forming processutilizing a replicate model of a dental structure obtained byconventional dental impression methods. The electronic and transducerassembly may receive incoming sounds either directly or through areceiver to process and amplify the signals and transmit the processedsounds via a vibrating transducer element coupled to a tooth or otherbone structure, such as the maxillary, mandibular, or palatine bonestructure.

In a military application as shown in FIG. 1C, the device 1 can includesensors that detect chemicals present in the soldier's saliva andprovide medical information on the soldier. Additionally, in certainembodiments, the device 1 can also sense heart rate, EKG, and otherbio-signals that can be picked up within the mouth. Additionally, thedevice 1 can communicate with the medical data collection modules thatcan collect heart rate. EKG, respiration rate, and other vital signs ormedical information. The device 1 can communicate with the GPS 2 andsensor modules through various short range radios such as a Bluetoothradio, for example, or through body conduction transceivers, amongothers.

During operation, the GPS can be used to provide detailed navigation forthe soldier.

An exemplary process to use the bone-conduction two way communicationduring a military mission can be as follows:

Remind user to use ear protection device upon power up.

Periodically collect position coordinates from team members, verballyguide the user to destination in coordination with team members, anddisplay the team member position for viewing.

Capture and respond to commands.

-   -   1) User can verbally request changes to radio communication        channels or volume settings, for example.    -   2) Rail mourned buttons can receive user actuations for a        particular operation where silence is required.

In another embodiment, the device 1 is custom-fit to the user and willnot be usable by another individual if transplanted to another user suchas through hostile action by an enemy or through an intentional actionby the wearer. This will be done by the fact that it is custom-fit tothe user. Further, in one embodiment, if the device is tampered with,anti-tampering circuitry in the device 1 will render the devicenon-functional.

The device 1 can also communicate with a long range transceiver such asa short-wave transceiver 3A, a cellular telephone transceiver 3B, or asatellite transceiver 3C. Such transceivers can be provided within thedevice 1, or alternatively, can be body worn. In the embodiment of FIG.1C, the satellite transceiver 3C is positioned on a belt worn by thesoldier. The satellite transceiver 3C communicates with the device 1through the short range radio such as Bluetooth, for example.

Although custom-fitted devices are shown and described, such devices arenot limited to being custom-fitted. Accordingly, these devices may alsoinclude those which are not manufactured to conform to the particularanatomy of any soldier such that e.g., dental impressions, are renderedunnecessary for the manufacture and use of the device as contemplatedherein. For instance, in one example, one or more biasing elements (asfurther described herein) may be positioned on or within the device suchthat the device exerts a pressure against one or more teeth of thesoldier (or other user) thereby facilitating secure contact of thedevice to the user. Moreover, use or applications of these devicesdescribed herein are not limited to soldiers or other military personnelbut may also be utilized by any number of other users, including, e.g.,law enforcement personnel, emergency personnel, etc.

The device 1 can contain a motion sensor such as an accelerometer. Themotion sensor can store information on external forces that are imposedon the user such as the forces arising from a bomb blast. Theaccelerometer measures the total specific external force on the sensor.The accelerometer can be a micro electro-mechanical system (MEMS) devicethat includes a suspended cantilever beam or proof mass (also known asseismic mass) with deflection sensing and circuitry. Other methods ofbuilding. MEMS based accelerometers are known.

In one embodiment, the accelerometer is a 3 axis accelerometer that cancapture the blast vector including direction and magnitude of the force.The blast vector is stored in memory and can also be transmitted to aremote monitoring center. For example, the motion sensor output can beprovided to the long range transceiver for remote monitoring of the wellbeing of the user. If a blast is detected, medical assistance can besent to save the user from harm. In another embodiment, historical blastvector information can be analyzed for injury trend analysis andsubsequent treatment even if the soldier reports no immediate medicalinjury,

In another embodiment, the accelerometer output is used to activate areactive personnel protection system which, upon detecting the presenceof a destructive force or object, interposes a protective shield betweenpersonnel under attack and the force in an almost instantaneous fashion.To protect against a concussive blast triggered by a bomb explosion, theoutput of the accelerometer triggers a rapid inflation of a vest 7A withan air bag worn by the user. The air bag can be fabricated from Kevlar®or similar materials. The air bag is rapidly inflated and interposedbetween a projectile or a concussive force and the person to beprotected so as to either deflect the projectile or reduce the effectsof the concussive force.

In another embodiment, the airbag can have a linkage 7C to a helmet 7Band the linkage is automatically inflated when the accelerometer sensesthe destructive force or object. When inflated, the vest 7A, the linkage7C and the helmet 7B is hardened to protect the user from neck injuryand other bodily harm(s).

The accelerometer senses an explosion or a bullet by sensing rapidchanges in acceleration and/or air pressure (e.g. the concussive wavefront which accompanies an explosion). Other devices, such asmagnetostrictive transducers, ultrasonic transducers, accelerometers,and other mechanical and/or electro-mechanical sensors can also beapplied to sense the occurrence of a concussive explosion:

The forces of the concussive explosion and/or vital signs of the usercan be automatically transmitted to a remote monitoring center that candispatch help if required. An exemplary process to collect medicalinformation from the patient and for supporting bone-conduction two waycommunication can be as follows:

Periodically collect medical information

Check to see if the soldier is using the long range transceiver fortalking

If long range transceiver is not used for talking, upload medicalhistory of the soldier to a remote computer over the long rangetransceiver

Remote computer detects if the medical data foils outside of anacceptable range that requires medical intervention

If medical intervention is required, the remote computer alerts thesoldier's commander for action to assist the soldier

Self-help instructions can be sent through the satellite transceiver tothe bone conduction communication device 1

In one embodiment, the medical data would include soldieridentification, triage status, condition, and treatment. The data wouldbe routed via the satellite transceiver to a Command Post where it isprocessed, stored, relayed to the Internet, and moved back to devices onthe field. As a result, data on casualties would be accessibleimmediately for operational use by other soldiers, medics, responders,incident commanders and even receiving hospitals that can help thesoldier. Real-time information regarding victims and their status iscritical to the overall management of field medical care. Medicalcommand can then coordinate timely information on the number ofcasualties and their needs with the known availability of resources,such as on-scene providers, ambulance locations, and area hospitalcapacities. Real-time information is also provided for determining theappropriate patient destination, depending on the type of injuries andthe capabilities of the receiving facilities.

In another embodiment, the remote computer can support a BATTLEFIELDMEDICAL INFORMATION SYSTEMS TACTICAL-JOINT (BMIST-J) for enablingmilitary providers to record, store, retrieve and transfer medicalrecords to the DoD's Clinical Data Repository by synchronizing thereceived data. The system supports digital versions of the DD 1380(field medical card) and SF 600 (chronological medical record of care).Diagnostic and treatment decision aids are provided by the system. Thedata captured by the device 1 is also Personal Information Carrier (PIC)compatible. The system provides a secure, legible, electronic records ofbattlefield treatments, contributes to a comprehensive, life-longmedical history, and facilitates medical surveillance.

Turning now to more details on the device 1, as shown in FIG. 1D, apatient's mouth and dentition 10 is illustrated showing one possiblelocation for removably attaching two-way communication assembly 14 uponor against at least one tooth, such as a molar 12. The patient's tongueTG and palate PL are also illustrated for reference. An electronicsand/or transducer assembly 16 may be attached, adhered, or otherwiseembedded into or upon the assembly 14, as described below in furtherdetail.

FIG. 2A shows a perspective view of the patient's lower dentitionillustrating the two-way communication assembly 14 comprising aremovable oral appliance 18 and the electronics and/or transducerassembly 16 positioned along a side surface of the assembly 14. In thisvariation, oral appliance 18 may be fitted upon two molars 12 withintooth engaging channel 20 defined by oral appliance 18 for stabilityupon the patient's teeth, although in other variations, a single molaror tooth may be utilized. Alternatively, more than two molars may beutilized for the oral appliance 18 to be attached upon or over.Moreover, electronics and/or transducer assembly 16 is shown positionedupon a side surface of oral appliance 18 such that the assembly 16 isaligned along a buccal surface of the tooth 12; however, other surfacessuch as the lingual, surface of the tooth 12 and other positions mayalso be utilized. The figures are illustrative of variations and are notintended to be limiting; accordingly, other configurations and shapesfor oral appliance 18 are intended to be included herein.

FIG. 2B shows another variation of a removable oral appliance in theform of an appliance 15 which is placed over an entire row of teeth inthe manner of a mouthguard. In this variation, appliance 15 may beconfigured to cover an entire bottom row of teeth or alternatively anentire upper row of teeth. In additional variations, rather thancovering the entire rows of teeth, a majority of the row of teeth may beinstead be covered by appliance 15. Assembly 16 may be positioned alongone or more portions of the oral appliance 15

FIG. 2C shows yet another variation of an oral appliance 17 having anarched configuration. In this appliance, one or more tooth retainingportions 21, 23, which in this variation may be placed along the upperrow of teeth, may be supported by an arch 19 which may lie adjacent oralong the palate of the user. As shown, electronics and/or transducerassembly 16 may be positioned along one or more portions of the toothretaining portions 21, 23. Moreover, although the variation shownillustrates an arch 19 which may cover only a portion of the palate ofthe user, other variations may he configured to have an arch whichcovers the entire palate of the user.

FIG. 2D illustrates yet another variation of an oral appliance in theform of a mouthguard or retainer 25 which may be inserted and removedeasily from the user's mouth. Such a mouthguard or retainer 25 may beused in sports where conventional mouthguards are worn; however,mouthguard or retainer 25 having assembly 16 integrated therein may beutilized by persons, hearing impaired or otherwise, who may simply holdthe mouthguard or retainer 25 via grooves or channels 26 between theirteeth for receiving instructions remotely and communicating over adistance.

Generally, the volume of electronics and/or transducer assembly 16 maybe minimized so as to be unobtrusive and as comfortable to the user whenplaced in the mouth. Although the size may be varied, a volume ofassembly 16 may be less than 800 cubic millimeters. This volume is, ofcourse, illustrative and not limiting as size and volume of assembly 16and may be varied accordingly between different users.

Moreover, removable oral appliance 18 may be fabricated from variouspolymeric or a combination of polymeric, and metallic materials usingany number of methods, such as computer-aided machining processes usingcomputer numerical control (CNC) systems or three-dimensional printingprocesses, e.g., stereolithography apparatus (SLA), selective lasersintering (SLS), and/or other similar processes utilizingthree-dimensional geometry of the patient's dentition, which may beobtained via any number of techniques. Such techniques may include useof scanned dentition using intra-oral scanners such as laser, whilelight, ultrasound, mechanical three-dimensional touch scanners, magneticresonance imaging (MRI), computed tomography (CT), other opticalmethods, etc.

In forming the removable oral appliance 18, the appliance 18 may beoptionally formed such that it is molded to fit over the dentition andat least a portion of the adjacent gingival tissue to inhibit the entryof food, fluids, and other debris into the oral appliance 18 and betweenthe transducer assembly and tooth surface. Moreover, the greater surfacearea of the oral appliance 18 may facilitate the placement andconfiguration of the assembly 16 onto the appliance 18.

Additionally, the removable oral appliance 18 may be optionallyfabricated to have a shrinkage factor such that when placed onto thedentition, oral appliance 18 may be configured to securely grab onto thetooth or teeth as the appliance 18 may have a resulting size slightlysmaller than the scanned tooth or teeth upon which the appliance 18 wasformed. The fitting may result in a secure interference fit between theappliance 18 and underlying dentition.

In one variation, with assembly 14 positioned upon the teeth, as shownin FIG. 3, an extra-buccal transmitter assembly 22 located outside thepatient's mouth may be utilized to receive auditory signals forprocessing and transmission via a wireless signal 24 to the electronicsand/or transducer assembly 16 positioned within the patient's mouth,which may then process and transmit the processed auditory signals viavibratory conductance to the underlying tooth and consequently to thepatient's inner ear.

The transmitter assembly 22, as described in further detail below, maycontain a microphone assembly as well as a transmitter assembly and maybe configured in any number of shapes and forms worn by the user, suchas a watch, necklace, lapel, phone, belt-mounted device, etc.

FIG. 4 illustrates a schematic representation of one variation oftwo-way communication assembly 14 utilizing art extra-buccal transmitterassembly 22, which may generally comprise microphone 30 for receivingsounds and which is electrically connected to processor 32 forprocessing the auditory signals. The assembly 14 includes motion sensor31 whose output is connected to processor 32. Motion sensor 31 can be athree axis accelerometer, among others. For small size, theaccelerometer can be a MEMS accelerometer. Processor 32 may be connectedelectrically to transmitter 34 for transmitting the processed signals tothe electronics and/or transducer assembly 16 disposed upon or adjacentto the user's teeth. The microphone 30 and processor 32 may beconfigured to detect and process auditory signals in any practicablerange, but may be configured in one variation to detect auditory signalsranging from, e.g., 250 Hertz to 20,000 Hertz.

With respect to microphone 30, a variety of various microphone systemsmay be utilized. For instance, microphone 30 may be a digital, analog,and/or directional type microphone. Such various types of microphonesmay be interchangeably configured to be utilized with the assembly, ifso desired.

Power supply 36 may be connected to each of the components intransmitter assembly 22 to provide power thereto. The transmittersignals 24 may be in any wireless form utilizing, radio frequency,ultrasound, microwave, Blue Tooth® (BLUETOOTH SIG, INC., Bellevue,Wash.), etc. for transmission to assembly 16. Assembly 22 may alsooptionally include one or more input controls 28 that a user maymanipulate to adjust various acoustic parameters of the electronicsand/or transducer assembly 16, such as acoustic focusing, volumecontrol, filtration, muting, frequency optimization, sound adjustments,and tone adjustments, etc.

The signals transmitted 24 by transmitter 34 may be received byelectronics and/or transducer assembly 16 via receiver 38, which may beconnected to an internal processor for additional processing of thereceived signals. The received signals may be communicated to transducer40, which may vibrate correspondingly against a surface of the tooth toconduct the vibratory signals through the tooth and bone andsubsequently to the middle ear to facilitate hearing of the user.Transducer 40 may be configured as any number of different vibratorymechanisms. For instance, in one variation, transducer 40 may be anelectromagnetically actuated transducer. In other variations, transducer40 may be in the form of a piezoelectric crystal having a range ofvibratory frequencies, e.g., between 250 to 4000 Hz.

Power supply 42 may also be included with assembly 16 to provide powerto the receiver, transducer, and/or processor, if also included.Although power supply 42 may be a simple battery, replaceable orpermanent, other variations may include a power supply 42 which ischarged by inductance via an external charger. Additionally, powersupply 42 may alternatively be charged via direct coupling, to analternating current (AC) or direct current (DC) source. Other variationsmay include a power supply 42 which is charged via a mechanicalmechanism, such as an internal pendulum or slidable electricalinductance charger as known in the art, which is actuated via, e.g.,motions of the jaw and/or movement for translating the mechanical motioninto stored electrical energy for charging power supply 42.

In another variation of assembly 16, rather than utilizing anextra-buccal transmitter, two-way communication assembly 50 may beconfigured as an independent assembly contained entirely within theuser's mouth, as shown in FIG. 5. Accordingly, assembly 50 may includean internal microphone 52 in communication with an on-board processor54. Internal microphone 52 may comprise any number of different types ofmicrophones, as described above. Processor 54 may be used to process anyreceived auditory signals for filtering, and/or amplifying the signalsand transmitting them to transducer 56, which is in vibratory contactagainst the tooth surface. Power supply 58, as described above, may alsobe included within assembly 50 for providing power to each of thecomponents of assembly 50 as necessary.

In order to transmit the vibrations corresponding to the receivedauditory signals efficiently and with minimal loss to the tooth orteeth, secure mechanical contact between the transducer and the tooth isideally maintained to ensure efficient vibratory communication.Accordingly, any number of mechanisms may be utilized to maintain thisvibratory communication.

In one variation as shown in FIG. 6A, a partial cross-sectional view ofa removable oral appliance 60 is shown placed over or upon a tooth TH.Electronics and/or transducer housing 62 may be seen defined along oralappliance 60 such that housing 62 is aligned or positioned adjacent to aside surface, buccal and/or lingual surface, of the tooth TH. Housing 62may provide protection to the electronics and/or transducer assemblyfrom the environment of the mouth.

An electronics and/or transducer assembly 64 may be simply placed,embedded, or encapsulated within housing 62 for contacting the toothsurface. In this variation, assembly 64 may be adhered against the toothsurface via an adhesive surface or film 66 such that contact ismaintained between the two. As shown in FIG. 6B, a removable backing 68may be adhered onto adhesive surface 66 and removed prior to placementupon the tooth surface. In this manner, assembly 64 may be replaced uponthe tooth as necessary with additional electronics and/or transducerassemblies,

Aside from an adhesive film 66, another alternative may utilize anexpandable or swellable member to ensure a secure mechanical contact ofthe transducer against the tooth. As shown in FIG. 7, an osmotic patchor expandable hydrogel 74 may be placed between housing 62 andelectronics and/or transducer assembly 72. After placement of oralappliance 60, hydrogel 74 may absorb some fluids, either from anysurrounding fluid or from a fluid introduced into hydrogel 74, such thathydrogel 74 expands in size to force assembly 72 into contact againstthe tooth surface. Assembly 72 may be configured to define a contactsurface 70 having a relatively smaller contact area to facilitateuniform contact of the surface 70 against the tooth. Such a contactsurface 70 may be included in any of the variations described herein.Additionally, a thin encapsulating layer or surface 76 may be placedover housing 62 between contact surface 70 and the underlying tooth toprevent any debris or additional fluids from entering housing 62.

Another variation is shown in FIG. 8, which shows electronics and/ortransducer assembly 80 contained within housing 62. In this variation,one or more biasing elements 82, e.g., springs, pre-formed shape memoryelements, etc., may be placed between assembly 80 and housing 62 toprovide a pressing force on assembly 80 to urge the device against theunderlying tooth surface, thereby ensuring mechanical contact.

In yet another variation, the electronics may be contained as a separateassembly 90 which is encapsulated within housing 62 and the transducer92 may be maintained separately from assembly 90 but also within housing62. As shown in FIG. 9, transducer 92 may be urged against the toothsurface via it spring or other biasing element 94 and actuated via anyof the mechanisms described above.

In other variations as shown in FIG. 10, electronics and/or transducerassembly 100 may be configured to have a ramped surface 102 inapposition to the tooth surface. The surface 102 may be angled away fromthe occlusal surface of the tooth. The assembly 100 may he urged via abiasing element or spring 106 which forces the ramped surface 102 topivot about a location 104 into contact against the tooth to ensurecontact for the transducer against the tooth surface.

FIG. 11 illustrates another similar variation in electronics and/ortransducer assembly 110 also having a ramped surface 112 in appositionto the tooth surface. In this variation, the ramped surface 112 may beangled towards the occlusal surface of the tooth. Likewise, assembly 110may be urged via a biasing element or spring 116 which urges theassembly 110 to pivot about its lower end such that the assembly 110contacts the tooth surface at a region 114.

In yet another variation shown in FIG. 12, electronics and/or transducerassembly 120 may be positioned within housing 62 with an interface layer122 positioned between the assembly 120 and the tooth surface. Interfacelayer 122 may be configured to conform against the tooth surface andagainst assembly 120 such that vibrations may be transmitted throughlayer 122 and to the tooth in a uniform manner. Accordingly, interfacelayer 122 may be made from a material which attenuates vibrationsminimally. Interface layer 122 may be made in a variety of forms, suchas a simple insert, an O-ring configuration, etc. or even in a gel orpaste form, such as denture or oral paste, etc. Additionally, layer 122may be fabricated from various materials, e.g., bard plastics orpolymeric materials, metals. etc.

FIG. 13 illustrates yet another variation in which electronics and/ortransducer assembly 130 may be urged against the tooth surface via amechanical mechanism. As shown, assembly 130 may be attached to astructural member 132, e.g., a threaded member or a simple shaft, whichis connected through housing 62 to an engagement member 134 locatedoutside housing 62. The user may rotate engagement member 134 (asindicated by rotational arrow 136) or simply push upon member 134 (asindicated by linear arrow 138) to urge assembly 130 into contact againstthe tooth. Moreover, actuation of engagement member 134 may beaccomplished manually within the mouth or through the user's cheek oreven through manipulation via the user's tongue against engagementmember 134.

Another variation for a mechanical mechanism is illustrated in FIG. 14.In this variation, electronics and/or transducer assembly 140 may definea portion as an engaging surface 142 for contacting against a cam orlever mechanism 144. Cam or lever mechanism 144 may be configured topivot 146 such that actuation of a lever 148 extending through housing62 may urge cam or lever mechanism 144 to push against engaging surface142 such that assembly 140 is pressed against the underlying toothsurface.

In yet another variation, the electronics 150 and the transducer 152 maybe separated from one another such that electronics 150 remain disposedwithin housing 62 but transducer 152, connected via wire 154, is locatedbeneath dental oral appliance 60 along an occlusal surface of the tooth,as shown in FIG. 15 in such a configuration vibrations are transmittedvia the transducer 152 through the occlusal surface of the tooth.Additionally, the user may bite down upon the oral appliance 60 andtransducer 152 to mechanically compress the transducer 152 against theocclusal surface to further enhance the mechanical contact between thetransducer 152 and underlying tooth to further facilitate transmissiontherethrough.

In the variation of FIG. 16, another example for a bite-enhancedcoupling mechanism is illustrated where electronics and/or transducerassembly 160 defines an angled interface surface 162 in apposition to acorrespondingly angled engaging, member 164. A proximal end of engaging,member 164 may extend through housing 62 and terminate in a pushermember 166 positioned over an occlusal surface of the tooth TH. Onceoral appliance 60 is initially placed over tooth TH, the user may bitedown or otherwise press down upon the top portion of oral appliance 60,thereby pressing down upon pusher member 166 which in turn pushes downupon engaging member 164, as indicated by the arrow. As engaging member164 is urged downwardly towards the gums, its angled surface may pushupon the corresponding and oppositely angled surface 162 to urgeassembly 160 against the tooth surface and into a secure mechanicalcontact.

In yet another variation, an electronics and/or transducer assembly 170may define a channel or groove 172 along a surface for engaging acorresponding dental anchor 174, as shown in FIG. 17, Dental anchor 174may comprise a light-curable acrylate-based composite material adhereddirectly to the tooth surface. Moreover dental anchor 174 may beconfigured in a shape which corresponds to a shape of channel or groove172 such that the two may be interfitted in a mating engagement. In thismanner, the transducer in assembly 170 may vibrate directly againstdental anchor 174 which may then transmit these signals directly intothe tooth TH.

FIGS. 18A and 18B show partial cross-sectional side and top views,respectively, of another variation in which oral appliance 180 maydefine a number of channels or grooves 184 along a top portion of oralappliance 180. Within these channels or grooves 184, one or moretransducers 182, 186, 188, 190 may be disposed such that they are incontact with the occlusal surface of the tooth and each of thesetransducers may be tuned to transmit frequencies uniformly.Alternatively, each of these transducers may be tuned to transmit onlyat specified frequency ranges. Accordingly, each transducer can beprogrammed or preset for a different frequency response such that eachtransducer may be optimized for a different frequency response and/ortransmission to deliver a relatively high-fidelity sound to the user.

In vet another variation, FIGS. 19A and 19B illustrate an oral appliance200 which may he pre-formed from a shape memory polymer or alloy or asuperelastic material such as a Nickel-Titanium alloy, e.g., Nitinol.FIG. 19A shows oral appliance 200 in a first configuration where members202, 204 are in an unbiased memory configuration. When placed upon oragainst the tooth TH, members 202, 204 ma be deflected into a secondconfiguration where members 202′, 204′ are deformed to engage tooth THin a secure interference fit, as shown in FIG. 19B. The biased member204 may he utilized to press the electronics and/or transducer assemblycontained therein against the tooth surface as well as to maintainsecurement of the oral appliance 200 upon the tooth TH.

Similarly, as shown in FIG. 20, removable oral appliance 210 may havebiased members to secure engage the tooth TH, as above. In thisvariation, the ends of the members 212, 214 may be configured intocurved portions under which a transducer element 218 coupled toelectronics assembly 216 may be wedged or otherwise secured to ensuremechanical contact against the tooth surface.

FIG. 21 shows yet another variation in which the oral appliance isomitted entirely. Here, a composite dental anchor or bracket 226, asdescribed above, may be adhered directly onto the tooth surface.Alternatively, bracket 226 may be comprised of a biocompatible material,e,g., stainless steel, Nickel-Titanium, Nickel, ceramics, composites,etc., formed into a bracket and anchored onto the tooth surface. Thebracket 226 may be configured to have a shape 228 over which anelectronics and/or transducer assembly 220 may be slid over or upon viaa channel 222 having a corresponding receiving configuration 224 forengagement with bracket 226. In this manner, assembly 220 may hedirectly engaged against bracket 226, through which a transducer maydirectly vibrate into the underlying tooth TH. Additionally, in theevent that assembly 220 is removed from the tooth TH, assembly 220 maybe simply slid, or rotated off bracket 226 and a replacement assemblymay be put in its place upon bracket 226.

FIGS. 22A and 22B show partial cross-sectional side and perspectiveviews, respectively, of yet another variation of an oral appliance 230.In this variation, the oral appliance 230 may be configured to omit anocclusal surface portion of the oral appliance 230 and instead engagesthe side surfaces of the tooth TH, such as the lingual and buccalsurfaces only. The electronics and/or transducer assembly 234 may becontained, as above, within a housing 232 for contact against the toothsurface. Additionally, as shown in FIG. 22B, one or more optionalcross-members 236 may connect the side portions of the oral appliance230 to provide some structural stability when placed upon the tooth.This variation may define an occlusal surface opening 238 such that whenplaced upon the tooth, the user may freely bite down directly upon thenatural occlusal surface of the tooth unobstructed by the oral appliancedevice, thereby providing for enhanced comfort to the user.

In yet other variations, vibrations may be transmitted directly into theunderlying bone or tissue structures rather than transmitting directlythrough the tooth or teeth of the user. As shown in FIG. 23A, an oralappliance 240 is illustrated positioned upon the user's tooth, in thisexample upon a molar located along the upper row of teeth. Theelectronics and/or transducer assembly 242 is shown as being locatedalong the buccal surface of the tooth. Rather than utilizing atransducer in contact with the tooth surface, a conduction transmissionmember 244, such as a rigid or solid metallic member, may be coupled tothe transducer in assembly 242 and extend from oral appliance 240 to apost or screw 246 which is implanted directly into the underlying bone248, such as the maxillary bone, as shown in the partial cross-sectionalview of FIG. 23B. As the distal end of transmission member 244 iscoupled directly to post or screw 246, the vibrations generated by thetransducer may be transmitted through transmission member 244 anddirectly into post or screw 246, which in turn transmits the vibrationsdirectly into and through the bone 248 for transmission to the user'sinner ear.

FIG. 24 illustrates a partial cross-sectional view of an oral appliance250 placed upon the user's tooth TH with the electronics and/ortransducer assembly 252 located along the lingual surface of the tooth.Similarly, the vibrations may be transmitted through the conductiontransmission member 244 and directly into post or screw 246, which inthis example is implanted into the palatine bone PL. Other variationsmay utilize this arrangement located along the lower row of teeth fortransmission to a post or screw 246 drilled into the mandibular bone.

In vet another variation, rather utilizing, a post or screw drilled intothe underlying bone itself, a transducer may be attached, coupled, orotherwise adhered directly to the gingival tissue surface adjacent tothe teeth. As shown in FIGS. 25A and 25B, an oral appliance 260 may havean electronics assembly 262 positioned along its side with an electricalwire 264 extending therefrom to a transducer assembly 266 attached tothe gingival tissue surface 268 next to the tooth TH. Transducerassembly 266 may be attached to the tissue surface 268 via an adhesive,structural support arm extending from oral appliance 260, a dental screwor post, or any other structural mechanism. In use, the transducer mayvibrate and transmit directly into the underlying gingival tissue, whichmay conduct the signals to the underlying bone.

For any of the variations described above, they may be utilized as asingle device or in combination with any other variation herein, aspracticable, to achieve the desired hearing level in the user. Moreover,more than one oral appliance device and electronics and/or transducerassemblies may be utilized at any one time. For example, FIG. 26illustrates one example where multiple transducer assemblies 270, 272,274, 276 may be placed on multiple teeth. Although shown on the lowerrow of teeth, multiple assemblies may alternatively be positioned andlocated along the upper row of teeth or both rows as well. Moreover,each of the assemblies may be configured to transmit vibrations within auniform frequency range. Alternatively in other variations, differentassemblies may be configured to vibrate within non-overlapping frequencyranges between each assembly. As mentioned above, each transducer 270,272, 274, 276 can he programmed or preset for a different frequencyresponse such that each transducer may be optimized for a differentfrequency response and/or transmission to deliver a relativelyhigh-fidelity sound to the user.

Moreover, each of the different transducers 270, 272, 274, 276 can alsobe programmed to vibrate in a manner which indicates the directionalityof sound received by the microphone worn by the user. For example,different transducers positioned at different locations within theuser's mouth can vibrate in a specified manner by providing sound orvibrational queues to inform the user which direction a sound wasdetected relative to an orientation of the user. For instance, a firsttransducer located, e.g., on a user's left tooth, can be programmed tovibrate for sound detected originating from the user's left side.Similarly, a second transducer located, e.g., on a user's right tooth,can be programmed to vibrate for sound detected originating from theuser's right side. Other variations and queues may be utilized as theseexamples are intended to be illustrative of potential variations.

In variations where the one or more microphones are positioned inintra-buccal locations, the microphone may be integrated directly intothe electronics and/or transducer assembly, as described above. However,in additional variation, the microphone unit may he positioned at adistance from the transducer assemblies to minimize feedback. In oneexample, similar to a variation shown above, microphone unit 282 may heseparated from electronics and/or transducer assembly 280, as shown inFIGS. 27A and 27B. In such a variation, the microphone unit 282positioned upon or adjacent to the gingival surface 268 may beelectrically connected via wire(s) 264.

Although the variation illustrates the microphone unit 282 placedadjacent to the gingival tissue 268, unit 282 may be positioned uponanother tooth or another location within the mouth. For instance, FIG.28 illustrates another variation 290 which utilizes an arch 19connecting one or more tooth retaining portions 21, 23, as describedabove. However, in this variation, the microphone unit 294 may beintegrated within or upon the arch 19 separated from the transducerassembly 292. One or more wires 296 routed through arch 19 mayelectrically connect the microphone unit 294 to the assembly 292.Alternatively, rather than utilizing a wire 296, microphone unit 294 andassembly 292 may be wirelessly coupled to one another, as describedabove.

In yet another variation for separating the microphone from thetransducer assembly, FIG. 29 illustrates another variation where atleast one microphone 302 (or optionally any number of additionalmicrophones 304, 306) may be positioned within the mouth of the userwhile physically separated from the electronics and/or transducerassembly 300. In this manner, the one or optionally more microphones302, 304, 306 may be wirelessly coupled to the electronics and/ortransducer assembly 300 in a manner which attenuates or eliminatesfeedback, if present, from the transducer.

The applications of the devices and methods discussed above are notlimited to the particular embodiments described but may include anynumber of further applications. Moreover, such devices and methods maybe applied to other sites within the body. Modification of theabove-described assemblies and methods for carrying out the invention,combinations between different variations as practicable, and variationsof aspects of the invention that are obvious to those of skill in theart are intended to be within the scope of the

1. A communication apparatus, comprising: a hone conductioncommunication apparatus, comprising: a housing having a shape which isconformable to at least a portion of at least one tooth of a user: atransceiver mounted in the housing; and a transducer disposed within orupon the housing and in vibratory communication with a surface of the atleast one tooth to transmit sound through the at least one tooth; and, acommunication device, coupled to the transceiver to link the user with asecond person.